FDA.reportPublic FDA data

Childrens Ibuprofen Oral Suspension

Product NDC
63868-796
11-digit product format
638680796
Labeler code
63868
Product ID
63868-796_5c369278-435d-4c67-991c-b4117eb90e4e
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA210602
Marketing category
ANDA
Marketing start
2020-12-15
Substance
IBUPROFEN
Active strength
100 mg/5mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Childrens Ibuprofen Oral Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-796-042022-12-18C16284748780-1d6a99b39-4c8e-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension
63868-796-042022-01-28C16284748780-1d6a99b39-4c8e-a426-e053-dadaa90af4c2Children's Ibuprofen Oral Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-796-04Childrens Ibuprofen Oral Suspension1 in 1 CARTONSUSPENSION15
63868-796-04Childrens Ibuprofen Oral Suspension118 mL in 1 BOTTLESUSPENSION1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-796-04ML - Milliliter63868-7969339924b-bb26-417c-8e6c-01936059771f12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-796CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [CHAIN DRUG MARKETING ASSOCIATION, INC.]5Current NDC, Legacy NDC, 2 package rows20241225_f0959369-890e-403e-8a98-4eda340a0783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNf0959369-890e-403e-8a98-4eda340a07835
197803ibuprofen 20 MG/ML Oral SuspensionSCDf0959369-890e-403e-8a98-4eda340a07835
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYf0959369-890e-403e-8a98-4eda340a07835
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYf0959369-890e-403e-8a98-4eda340a07835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-796-04638680796041 BOTTLE in 1 CARTON (63868-796-04) / 118 mL in 1 BOTTLE1 bottle2020-12-152023-12-31NoNoCurrent